Adverse Events Module

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Adverse Events Module

For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.

Adverse Events Module path is as follows:

Study -> Results Section -> Adverse Events Module -> Event Groups

Study -> Results Section -> Adverse Events Module -> Serious Events

Study -> Results Section -> Adverse Events Module -> Other Events

Adverse Events Module

Ignite Creation Date: 2025-12-26 @ 11:12 PM
Ignite Modification Date: 2025-12-26 @ 11:12 PM
NCT ID: NCT03707912
Description: None
Frequency Threshold: 0
Time Frame: 7 days
Study: NCT03707912
Study Brief: Clinical Trial of Efficacy and Safety of Anaferon in the Treatment of Acute Respiratory Viral Infections
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Anaferon 1 tablet per administration. Day 1: 1 tablet every 30 minutes for the first 2 hours, followed by 3 more tablets taken at regular intervals through the rest of the day. Days 2-5: 1 tablet 3 times a day. The drug is taken out of the meal (in the interval between meals or 15-30 minutes before eating), keep the tablet in the mouth, without swallowing, until completely dissolved. Anaferon: Oral administration. 0 None 0 104 5 104 View
Placebo Placebo using Anaferon regimen until the end of the study. Placebo: Oral administration. 0 None 0 100 5 100 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Intoxication Syndrome Intensification SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Community-acquired pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Acute tracheobronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Community-acquired bacterial infection with bacterial bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Community-acquired bacterial infection with purulent rhinitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Acute tracheitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Acute bronchitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View